Abstract
The Animal and Plant Health Inspection Service within the United Stated Department of Agriculture (USDA) recently updated the biotechnology regulations (7 C.F.R. Part 340) under the Plant Protection Act (85 Fed. Reg. 29790, May 18, 2020). The framework is defined as the Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule . It covers plants generated through techniques that use recombinant, synthetic, and/or amplified nucleic acid to modify a genome.
This is arguably the most significant, and perhaps overdue, new regulatory framework for plant breeding since 1987. This milestone ushers in a new era for the use and management of molecular breeding techniques for plants in general and commercial crops in particular. Given the profound technological changes since the 1980s, especially in genome editing, this is crucial at a time when food access, security, safety, and sustainability are most critical. This giant leap for USDA and smaller step for CRISPR opens the door for broader, more democratic use of these technologies. It also sets the tone for other countries and regulatory agencies to update their regulatory frameworks and policies.
Three years in the making, the amendment regulates the movement and environmental release of genetically engineered plants and establishes a reduced regulatory burden for the “introduction of organisms and products altered or produced through genetic engineering.” 1 Notably, exemptions are defined that apply to plants that have been modified with deletions (of any size), a single base-pair substitution, and introduction of sequences from within the plant's natural gene pool, as well as offspring of genetically engineered plants that do not retain the genetic modification of the genome-edited parent. The focus rests on the organism itself rather than the methods and technologies used to generate it, which is important given improvements in delivery and genome editing modalities over the past 33 years.
Conveniently, this enables users to exploit more freely best-in-class elite plant germplasm delivery techniques and put to work CRISPR effectors for certain types of editing without being regulated. Start-up companies in particular will benefit in many ways by not being burdened with the regulatory processes, including practical (conserving resources), financial (fewer requirements and paperwork), and time benefits, helping organizations demonstrate progress toward product development and commercialization between funding rounds.
This welcome update from USDA is encouraging given the overall rise in appreciation and support for genome editing technologies and their myriad applications in agriculture, biotechnology, and medicine. Deletions, substitutions, and reliance on endogenous repair pathways using CRISPR effectors that are more specific and efficient than alternative random mutation approaches opens the door for knockouts and loss-of-function applications.
The ability to introduce sequences from within the plant's natural gene pool expands the genetic biodiversity potential and enables scientists to broaden candidate alleles beyond elite germplasm. Rather than limit options to select proprietary genotypes that historically show strong yield in commercial farms, scientists can now openly consider all variants in the species of interest and broaden the genetic potential for select genes and alleles of interest, without the systematic need to actually breed hybrids and select or screen for desirable offspring. This provides benefits in time and resources, as well as an incentive to use and exploit biodiversity in commercial crops.
Challenges Ahead
There are, however, some technical limitations with regard to insertions and multiplexed editing, when most key traits and phenotypes rely on a complex combination of, and interactions between, multiple genetic elements. Predictably, advocates and detractors have expressed concerns reminiscent of tensions around the clinical use of genome editing therapies. Others worry about transparency, the continued reliance on filings by organizations incentivized to fall under deregulated status, and the need to have a process that pays more attention to public concerns about genetically modified (GM) food products.
One key element is the actual role of regulatory agencies such as the USDA, which is to “provide leadership on food, agriculture, natural resources, rural development, nutrition, and related issues based on public policy, the best available science, and effective management.” 2 This balancing act must support agricultural economic development at the domestic level and preserve national resources, while managing ecological risks and consumer safety.
A constant challenge is that even after three decades of broad consumption (at least domestically in the United States) of GM crops and despite a plethora of scientific studies and reports documenting their safe use and consumption, there are still concerns about molecular breeding science, genome editing technologies, and products derived from these crops. This means we must do more to build consumer trust and highlight the benefits and value for food safety, sustainability, and environmental stewardship, while relying on science-informed policies and promoting transparency.
We must also do more to address consumer concerns about the foods they eat and the regulatory processes that encompass them. The dialogue between regulators and breeders will continue under this framework and will evolve over time with petitions for “nonregulated” status and regulatory status reviews, but consumers often feel left out of the process, as illustrated by the misunderstood (and often misused) commentary period. Such agencies must maintain regulatory legitimacy and provide leadership.
As a journal that cares about the public acceptance of genome editing, we believe that science-informed policies and frameworks are the defensible standard. This will require more studies on understanding the potential risk and benefit differences between conventional and molecular breeding, at a time when the outcomes of genome editing can be identical to traditional breeding.
Trust and Transparency
We believe this updated USDA framework is an important step in the right direction towards a new regulatory era. It opens the door for exploitation of genetic biodiversity within species, incentivizing and enabling breeders to better understand the broad genetic pool of a given species. It also opens new avenues to restore and reconsider non-elite variants that have the potential to address many agricultural challenges beyond yield and pest resistance, such as resilience. Importantly, it also promotes the use of science and technology in industry and academia to enable the development of next-generation food products with enhanced attributes and sustainability.
Rather than wonder whether we are going too fast or in the right direction, let's ask if we are being transparent enough. Are we trustworthy? This is the time to rise to the transparency, public confidence, and communication challenge.